MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97712

Device Problems Failure to Deliver Energy (1211); Charging Problem (2892); Connection Problem (2900); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 01/08/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 97740, serial# (b)(4), product type: programmer, patient.Product id 97754, serial# (b)(4), product type: recharger.Product id 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id 37761, serial# (b)(4), product type: recharger.Product id 37761, serial# (b)(4), product type: recharger.Analysis of the 37761 desktop charger (serial# (b)(4)) found a broken connector pin.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a family member regarding a patient who was implanted with a neurostimulator for spinal pain.It was reported that the recharger (insr) was not charging.The insr was not responsive when plugged in, and there was a suspected bent/broken connector pin on the desktop charger.Four days later the patient had not yet received the replacement insr and noted that the implantable neurostimulator/ stimulation had shut off the night before.Upon device return, the insr was found to have a cable assembly with a broken connector.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5541055
• MDR Text Key: 41667346
• Report Number: 3004209178-2016-05871
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2014
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2015
• Initial Date FDA Received: 04/01/2016
• Supplement Dates Manufacturer Received: 01/08/2015
• Supplement Dates FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 00045 YR